The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .

The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject is 18 years and older

Be admitted to the hospital

One of the following two criteria:

Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria:

Contraindications for anticoagulation

Recurrent PE despite adequate anticoagulation

Emergency treatment following massive pulmonary embolism

Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including:

Patients with multiple trauma and active or recent bleeding with contraindications to anticoagulation or that require a temporary stop of anticoagulation

severe head injury with coma

severe hemorrhagic stroke with coma

head injury with a long bone fracture

spinal cord injury with paraplegia or quadriplegia

multiple (≥2) long bone fractures with pelvic fracture

multiple (≥4) long bone fractures

Critically ill patients in the Medical or Surgical Intensive Care Unit with high risk of PE that require but are contraindicated for anticoagulation prophylaxis and will benefit from a temporary filter and a central venous access catheter

Patients who had recently undergone or are about to undergo a surgical procedure that requires temporary interruption of anticoagulation for Venous Thromboembolism (VTE) and will benefit from a temporary vena cava filter and central

Participation in another simultaneous interventional medical investigation or interventional trial.

Patient has indications for a permanent filter at the time of the initial evaluation

Patient has an uncontrollable coagulopathy with active bleeding.

Patient with proven endocarditis or bacteremia

Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol

Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins

Patient with functioning pelvic renal allograft on the only side available for device insertion

Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403090